Rev.3.3 User Manual Page 21 of 299
12. LABELS & SYMBOLS
Symbols are described in the table below
Manufacturer’s name and address
This product is a certified Class IIa medical device, and complies with the requirements of
Directive 93/42/EEC.
In accordance with IEC 60601–1 the product and its applied parts are type BF and thus
protected against the risks of electrical leakage.
This symbol is required by European directive 2002/96/EEC on waste electrical and
electronic equipment (WEEE). At the end of its useful life this device must not be disposed
of as normal domestic waste. Instead it must be delivered to a WEEE authorised collection
centre. As an alternative, the device may be returned without charge to the dealer or
distributor, when it is replaced by another equivalent device.
Due to the construction materials used for the device, disposal as normal waste could
cause harm to the environment and/or health. Failure to observe these regulations can
lead to prosecution.
Indicates the degree of resistance to liquids. The device is protected against falling drops
of water if it is disposed up to 15° from vertical.
The symbol is used in accordance with IEC EN 60601–1–2: 2007 in section 5.1.1 for
products including RF transmitters.
Identification showing traceability to FCC compliance
SMART ONE complies with the Essential Requirements of Directive 93/42/EEC on Medical Devices.
This statement is made on the basis of CE Certificate no. MED 9826 issued by Kiwa Cermet,
Notified Body no. 0476.
13. TECHNICAL SPECIFICATIONS
Forced Expiratory Volume in 1 second
Bi–directional turbine (rotating blade)
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